Futura Medical, a healthcare company focused on advanced transdermal technology, has gotten EU approval to manufacture CSD500, the company’s novel, erectogenic condom with an extended shelf life for the product of 18 months.
TTK (TTK Protective Devices Limited), part of the substantial Indian conglomerate TTK Group, is one of Futura’s two manufacturing partners for CSD500. In addition to manufacturing CSD500 for worldwide distribution, TTK will also market and distribute CSD500 in India under its SKORE brand, the fastest growing condom brand in India, said the Futura in its press release.
A separate regulatory submission (filed after the TTK submission) for the Company’s European manufacturing partner to manufacture CSD500 with the extended shelf life of 18 months is also under review with the same relevant EU Notified Body. Confirmation will be made in due course as to the outcome of this submission.
James Barder, Futura’s Chief Executive, commented: “At the time of our half year results in September, we highlighted that regulatory approval was imminent for TTK to manufacture CSD500 with an extended shelf life of 18 months. This is in line with the requirements of our commercial partners and we are pleased that this approval has now been received.”
Barder added: “Our manufacturing strategy for CSD500 comprises two manufacturing centres: one in Asia and one in Europe. Now that approval for our Asian manufacturer has been received, we will focus on obtaining the approval for our European manufacturer.”